Overview
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the liver to form the active aldophosphamide. It has been used in the treatment of lymphoma and leukemia. Its side effect, alopecia, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Indication
Cyclophosphamide is indicated for the treatment of malignant lymphomas, multiple myeloma, leukemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast. It is also indicated for the treatment of biopsy-proven minimal change nephrotic syndrome in pediatric patients.
Associated Conditions
- Acute Lymphoblastic Leukaemias (ALL)
- Acute Myeloid Leukemia
- Acute monocytic leukemia
- Adenocarcinoma of the Ovaries
- Breast Cancer
- Burkitt Lymphoma
- Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia (CML)
- Hodgkins Disease (HD)
- Lung Cancer
- Lupus
- Lymphocytic Lymphomas
- Lymphoma
- Multiple Myeloma (MM)
- Multiple Sclerosis
- Nephrotic syndrome with lesion of minimal change glomerulonephritis
- Non-Hodgkin's Lymphoma (NHL)
- Retinoblastoma
- Advanced Alibert-Bazin syndrome
- Chronic Granulocytic Leukemias
- Disseminated Neuroblastoma (NB)
- Histiocytic lymphoma
- Mixed-cell type lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/22 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/07/20 | Not Applicable | Active, not recruiting | The First Affiliated Hospital of Soochow University | ||
2025/07/18 | Not Applicable | Not yet recruiting | |||
2025/07/15 | Not Applicable | Not yet recruiting | TriArm Therapeutics (Taiwan) Limited | ||
2025/07/09 | Not Applicable | Not yet recruiting | |||
2025/07/04 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | PETHEMA Foundation | ||
2025/06/26 | Phase 1 | ENROLLING_BY_INVITATION | |||
2025/06/25 | Phase 1 | Not yet recruiting | |||
2025/06/24 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 10019-957 | INTRAVENOUS, ORAL | 2 g in 100 mL | 10/25/2014 | |
| Baxter Healthcare Corporation | 10019-956 | INTRAVENOUS, ORAL | 1 g in 50 mL | 10/25/2014 | |
| AuroMedics Pharma LLC | 55150-271 | INTRAVENOUS | 1 g in 5 mL | 9/8/2021 | |
| STI Pharma LLC | 54879-021 | ORAL | 25 mg in 1 1 | 1/12/2024 | |
| Sandoz Inc. | 0781-3233 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 12/22/2021 | |
| Civica, Inc. | 72572-087 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 7/31/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-618 | ORAL | 25 mg in 1 1 | 2/17/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1240 | INTRAVENOUS, ORAL | 2 g in 100 mL | 11/3/2023 | |
| Long Grove Pharmaceuticals, LLC | 81298-8110 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 11/10/2023 | |
| NorthStar RxLLC | 72603-104 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 10/11/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENDOXAN FOR INJECTION 500 mg/vial | SIN01748P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 6/9/1988 | |
| CYCRAM FOR INJECTION 1 g/vial | SIN10355P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 11/3/1998 | |
| ENDOXAN TABLET 50 mg | SIN00929P | TABLET, SUGAR COATED | 50 mg | 5/9/1988 | |
| ENDOXAN FOR INJECTION 1 g/vial | SIN01747P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 6/9/1988 | |
| ENDOXAN FOR INJECTION 200 mg/vial | SIN00930P | INJECTION, POWDER, FOR SOLUTION | 200 mg/vial | 5/9/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 1000 mg powder for injection vial | 361545 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 1000 mg powder for injection vial | 361548 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 500 mg powder for injection vial | 361555 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 500 mg powder for injection vial | 361544 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 2000 mg powder for injection vial | 361558 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 2000 mg powder for injection vial | 361547 | Medicine | A | 3/7/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE FOR INJECTION USP | andone pharmaceutical inc | 02546736 | Powder For Solution - Intravenous | 1000 MG / VIAL | 6/6/2025 |
| PROCYTOX TABLETS 50MG | carter-horner corp. | 00013749 | Tablet - Oral | 50 MG / TAB | 12/31/1959 |
| PROCYTOX | baxter corporation | 02241797 | Powder For Solution - Intravenous | 200 MG / VIAL | 11/26/2000 |
| PROCYTOX TAB 50MG | baxter corporation | 02241796 | Tablet - Oral | 50 MG | 8/22/2000 |
| PROCYTOX FOR INJECTION 2000MG PWS IV | carter-horner corp. | 02094428 | Powder For Solution - Intravenous | 2 G / VIAL | 12/31/1994 |
| PROCYTOX VIAL 200MG | carter-horner corp. | 00013544 | Powder For Solution - Intravenous | 200 MG / VIAL | 12/31/1959 |
| CYTOXAN TAB 25MG | bristol-myers squibb canada | 00344877 | Tablet - Oral | 25 MG | 12/31/1977 |
| CYCLOPHOSPHAMIDE FOR INJECTION | 02531046 | Powder For Solution - Intravenous | 2000 MG / VIAL | N/A | |
| CYCLOPHOSPHAMIDE FOR INJECTION | 02531038 | Powder For Solution - Intravenous | 1000 MG / VIAL | N/A | |
| PROCYTOX | baxter corporation | 02241800 | Powder For Solution - Intravenous | 2000 MG / VIAL | 11/3/2003 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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